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Results For "IMA"

3216 News Found

Lupin receives tentative approval from USFDA for Dasatinib Tablets
Drug Approval | August 29, 2022

Lupin receives tentative approval from USFDA for Dasatinib Tablets

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).


Dr. Mansukh Mandaviya and Bhagwanth Khuba to grace Silver Jubilee function of NPPA
News | August 29, 2022

Dr. Mansukh Mandaviya and Bhagwanth Khuba to grace Silver Jubilee function of NPPA

To mark the occasion, Integrated Pharmaceutical Database Management System 2.0 (IPDMS 2.0), an integrated responsive cloud-based application developed by NPPA with technical support from C-DAC will be launched


Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP
Drug Approval | August 29, 2022

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).


Moderna sues Pfizer, BioNTech for mRNA patent infringement
News | August 28, 2022

Moderna sues Pfizer, BioNTech for mRNA patent infringement

Complaints to be filed in both United States and Germany alleging that Pfizer and BioNTech's COVID-19 vaccine Comirnaty unlawfully infringes patents Moderna filed between 2010 and 2016


Syngene International forms a new subsidiary
News | August 28, 2022

Syngene International forms a new subsidiary

The company shall be engaged in the business of manufacturing of pharmaceutical, bio-pharmaceutical and biological products of any kind


Syngene International to acquire stake in O2 Renewable Energy II
News | August 28, 2022

Syngene International to acquire stake in O2 Renewable Energy II

A special purpose vehicle (SPV) formed by O2 Energy SG Pte Ltd, for generation and supply of renewable power


Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada
News | August 27, 2022

Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada

With the receipt of the EIR, the inspection stands successfully closed.


Lupin launches Desvenlafaxine extended-release tablets in the US
News | August 27, 2022

Lupin launches Desvenlafaxine extended-release tablets in the US

Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.


Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER
Drug Approval | August 27, 2022

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).


Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients